1. Pink Sheet
  2. >>R&D

Could REGEN-COV’s New US FDA Emergency Use Authorization Revive COVID-19 Prophylaxis Pipeline?

 
• By Bridget Silverman

Regeneron’s neutralizing antibody cocktail earned the first post-exposure prophylaxis EUA for COVID-19, but the new use and dosing improvements need to overcome slow uptake under the original authorization for the COVID-19 treatment and the poisoned environment left by hydroxychloroquine controversies.

Prophylaxis
The post-exposure prophylaxis EUA highlighted the needs of immunocompromised patients, Regeneron's president said. • Source: Alamy

The FDA’s addition of post-exposure prophylaxis for COVID-19 to the emergency use authorization for Regeneron Pharmaceuticals, Inc.’s monoclonal antibody therapy REGEN-COV (casirivimab and imdevimab) on 30 July marks the biggest advance yet for pre- and post-exposure prophylaxis strategies to manage SARS-CoV-2, which aim to reduce the chance that unvaccinated people in close contact with COVID-19 patients will become ill.

The revised EUA clears REGEN-COV for post-exposure prophylaxis in adults and children 12 years and up who weigh at least...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from R&D

Elevidys Helps Sarepta To First US FDA Platform Technology Designation

 
• By Bridget Silverman

Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.

More from Pink Sheet

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.